FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Akorn, Inc. — Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Dist…Class II · 2023-04-26
Akorn, Inc. — XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3m…Class II · 2023-04-26
Akorn, Inc. — Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, …Class II · 2023-04-26
Akorn, Inc. — Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: …Class II · 2023-04-26
Akorn, Inc. — Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufacture…Class III · 2020-02-21
Akorn, Inc. — Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or I…Class II · 2023-04-26
Akorn, Inc. — Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g …Class III · 2020-02-21
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only,…Class II · 2023-04-26
Akorn, Inc. — CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, …Class III · 2020-02-21
Akorn, Inc. — Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles,…Class II · 2023-04-26
Akorn, Inc. — Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles,…Class II · 2023-04-26
Akorn, Inc. — Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL)…Class II · 2023-04-26
Akorn, Inc. — Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Di…Class II · 2023-04-26
Akorn, Inc. — ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl.…Class II · 2016-03-23
Akorn, Inc. — Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (47…Class II · 2016-03-23
Akorn, Inc. — PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 …Class II · 2016-03-23
Akorn, Inc. — Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufact…Class II · 2018-06-22
Akorn, Inc. — Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only,…Class II · 2016-05-17
Akorn, Inc. — Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx on…Class II · 2019-02-22
Akorn, Inc. — SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg …Class II · 2015-03-17
Akorn, Inc. — SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg …Class II · 2015-03-17
Akorn, Inc. — SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg…Class II · 2015-03-17
Akorn, Inc. — Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufac…Class II · 2018-08-01
Akorn, Inc. — Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottl…Class III · 2019-03-28
Akorn, Inc. — Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (4…Class II · 2015-04-07
Akorn, Inc. — Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (4…Class II · 2015-04-07
Akorn, Inc. — Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, …Class III · 2018-08-08
Akorn, Inc. — Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 …Class II · 2022-06-10
Akorn, Inc. — Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight…Class II · 2022-06-13
Akorn, Inc. — Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only,…Class II · 2018-08-24
Akorn, Inc. — Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin)…Class III · 2018-10-29
Akorn, Inc. — Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle…Class III · 2020-06-05
Akorn, Inc. — Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per …Class III · 2019-12-26
Akorn, Inc. — IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478…Class III · 2015-04-20
Akorn, Inc. — Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx…Class III · 2016-07-27
Akorn, Inc. — Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, …Class II · 2022-08-31
Akorn, Inc. — Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1…Class II · 2022-08-31
Akorn, Inc. — Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed…Class II · 2022-09-21
Akorn, Inc. — Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30)…Class II · 2022-09-21
Akorn, Inc. — Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in steri…Class III · 2014-08-05
Akorn, Inc. — Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Steri…Class II · 2020-09-03
Akorn, Inc. — Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use …Class III · 2019-08-06
Akorn, Inc. — Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use …Class III · 2019-08-06
Akorn, Inc. — Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Via…Class III · 2019-08-06
Akorn, Inc. — Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile,…Class II · 2019-09-17
Akorn, Inc. — Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bot…Class II · 2019-09-20
Akron Pharma, Inc. — OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Soft…Class II · 2024-10-15
Akron Pharma, Inc. — Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Ph…Class III · 2024-12-12
Akron Pharma, Inc. — Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron…Class III · 2024-12-12
Akron Pharma, Inc. — Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, …Class III · 2024-12-12
Akron Pharma, Inc. — Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron P…Class III · 2024-12-12
Akron Pharma, Inc. — Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Man…Class III · 2024-12-12
Akron Pharma, Inc. — Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Ma…Class III · 2024-12-12
Akron Pharma, Inc. — Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Ma…Class III · 2024-12-12
Akron Pharma, Inc. — DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: …Class III · 2023-02-17
Akron Pharma, Inc. — Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 7…Class III · 2022-08-04
Akron Pharma, Inc. — Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count…Class III · 2022-08-04
Aksar LLC — AKSAR (life taste and beyond) Cashew Pieces 4040615 Net Wt: 7o…Class I · 2015-05-20
AKT Trading Inc. — Menma Ajitsuke prepared bamboo shoots; Product of Japan; Manufactured…Class I · 2025-01-15
AKT Trading Inc. — Choshiya branded "SHIBA ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 45…Class I · 2025-02-18
AKT Trading Inc. — Choshiya branded "AOKAPPA ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE …Class I · 2025-02-18
AKT Trading Inc. — Choshiya branded "FUKUSHIN ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE…Class I · 2025-02-18
AKT Trading Inc. — Choshiya branded "SOFT TSUBOZUKE PREPARED MIX VEGETABLES" UPC# JANCOD…Class I · 2025-02-18
AKT Trading Inc. — Choshiya branded "RAKKYO ZUKE PREPARED VEGETABLES" UPC# JANCODE 49836…Class I · 2025-02-18
AKT Trading Inc. — Choshiya branded "MENMA AJITSUKE PREPARED BAMBOO SHOOTS" UPC# JANCODE…Class I · 2025-02-18
AL'S PICADERA — LBL reads in part:*** AL'S PICADERA*** MANTENGASE REFRIGERADO ENTRE…Class I · 2015-01-23
Alanwar Food Corp. — Sonex brand aluminum pot; ISO 9001:2000; Made in PakistanClass I · 2025-11-19
Alara Pharmaceutical Co — Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufact…Class II · 2012-10-29
Alaska Pasta Company — Fettuccine. Product is made refrigerated. Product is packaged in …Class II · 2017-05-22
Alaska Pasta Company — Fettuccine Gluten Free. Product is made refrigerated. Product is p…Class II · 2017-05-22
Alaska Pasta Company — Gemelli. Product is made refrigerated. Product is packaged in plas…Class II · 2017-05-22
Alaska Pasta Company — Lasagne Sheets. Product is made refrigerated. Product is packaged …Class II · 2017-05-22
Alaska Pasta Company — Lasagne Sheets Spinach. Product is made refrigerated. Product is p…Class II · 2017-05-22
Alaska Pasta Company — Linguine. Product is made refrigerated. Product is packaged in pla…Class II · 2017-05-22
Alaska Pasta Company — Papperdelli ¿ inch. Product is made refrigerated. Product is packa…Class II · 2017-05-22
Alaska Pasta Company — Penne. Product is made refrigerated. Product is packaged in plasti…Class II · 2017-05-22
Alaska Pasta Company — Ravioli Butternut. Product is made refrigerated. Product is packag…Class II · 2017-05-22
Alaska Pasta Company — Ravioli Cheese. Product is frozen. Product is packaged in plastic …Class II · 2017-05-22
Alaska Pasta Company — Ravioli Lobster. Product is made refrigerated. Product is package…Class II · 2017-05-22
Alaska Pasta Company — Ravioli Mushroom. Product is made refrigerated. Product is packag…Class II · 2017-05-22
Alaska Pasta Company — Ravioli Orso. Product is made refrigerated. Product is packaged i…Class II · 2017-05-22
Alaska Pasta Company — Ravioli Spinach. Product is made refrigerated. Product is packaged…Class II · 2017-05-22
Alaska Pasta Company — Riggatoni. Product is made refrigerated. Product is packaged in pl…Class II · 2017-05-22
Alaska Pasta Company — Shells. Product is made refrigerated. Product is packaged in plast…Class II · 2017-05-22
Alaska Pasta Company — Spaghettoni. Product is made refrigerated. Product is packaged in …Class II · 2017-05-22
Alb-USA Enterprises Inc — ALB Flavor brand CINNAMON Powder; 100 g; ALB-USA Enterprises Inc 529 …Class II · 2024-07-25
Alb-USA Enterprises Inc — El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in d…Class II · 2026-05-21
Albanese Confectionery Group, Inc. — Albanese Dark Chocolate Espresso Bean packaged into 9oz plastic tubs…Class I · 2022-03-09
Albanese Confectionery Group, Inc. — Albanese World's Best Mini Gummi Butterflies 7.5oz UPC 634418523525Class II · 2021-08-18
Albanese Confectionery Group, Inc. — Rich s Milk Chocolate Giant Layered Peanut Butter and Cups Rich s Mil…Class I · 2022-05-26
Albek De Mexico S.A. De C.V. — NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethy…Class II · 2020-07-30
Albek De Mexico S.A. De C.V. — Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl …Class II · 2020-07-30
Albek De Mexico S.A. De C.V. — Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70%…Class II · 2020-07-30
Albek De Mexico S.A. De C.V. — Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% …Class II · 2020-07-30
Albek De Mexico S.A. De C.V. — NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL …Class II · 2020-07-30
Albertsons Companies LLC — Ready Meals Shrimp Cooked with Cocktail Sauce SCE NET WT 12 OZ CAL 33…Class I · 2022-08-29
Albertsons Companies LLC — Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 …Class II · 2022-08-29
Albertsons Companies LLC — ReadyMeals Chicken Salad Quad, 12 oz., in a clear plastic container w…Class I · 2022-10-17
Albertsons Companies LLC — Chicken Salad Sandwich Club 18 Inch Tray, Black tray with 16 pre-made…Class I · 2022-10-17
Albertsons Companies LLC — (1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC 212916000…Class II · 2024-10-10